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Abstract：
Janus kinase inhibitors (JAKi) have been approved for use in various immune-mediated inflammatory diseases. With five agents licensed, it was timely to summarise the current understanding of JAKi use based on a systematic literature review (SLR) on efficacy and safety.
Existing data were evaluated by a steering committee and subsequently reviewed by a 29 person expert committee leading to the formulation of a consensus statement that may assist the clinicians, patients and other stakeholders once the decision is made to commence a JAKi. The committee included patients, rheumatologists, a gastroenterologist, a haematologist, a dermatologist, an infectious disease specialist and a health professional. The SLR informed the Task Force on controlled and open clinical trials, registry data, phase 4 trials and meta-analyses. In addition, approval of new compounds by, and warnings from regulators that were issued after the end of the SLR search date were taken into consideration.
The Task Force agreed on and developed four general principles and a total of 26 points for consideration which were grouped into six areas addressing indications, treatment dose and comedication, contraindications, pretreatment screening and risks, laboratory and clinical follow-up examinations, and adverse events. Levels of evidence and strengths of recommendations were determined based on the SLR and levels of agreement were voted on for every point, reaching a range between 8.8 and 9.9 on a 10-point scale.
The consensus provides an assessment of evidence for efficacy and safety of an important therapeutic class with guidance on issues of practical management.
Existing data were evaluated by a steering committee and subsequently reviewed by a 29 person expert committee leading to the formulation of a consensus statement that may assist the clinicians, patients and other stakeholders once the decision is made to commence a JAKi. The committee included patients, rheumatologists, a gastroenterologist, a haematologist, a dermatologist, an infectious disease specialist and a health professional. The SLR informed the Task Force on controlled and open clinical trials, registry data, phase 4 trials and meta-analyses. In addition, approval of new compounds by, and warnings from regulators that were issued after the end of the SLR search date were taken into consideration.
The Task Force agreed on and developed four general principles and a total of 26 points for consideration which were grouped into six areas addressing indications, treatment dose and comedication, contraindications, pretreatment screening and risks, laboratory and clinical follow-up examinations, and adverse events. Levels of evidence and strengths of recommendations were determined based on the SLR and levels of agreement were voted on for every point, reaching a range between 8.8 and 9.9 on a 10-point scale.
The consensus provides an assessment of evidence for efficacy and safety of an important therapeutic class with guidance on issues of practical management.
摘要：
Janus激酶抑制剂(JAKi)已被批准用于各种免疫介导的炎性疾病。有五名特工执照，根据关于疗效和安全性的系统文献综述(SLR),总结目前对JAKI使用的理解是及时的.
指导委员会对现有数据进行了评估，随后由一个29人的专家委员会进行了审查，从而制定了一份可能有助于临床医生的共识声明。患者和其他利益相关者一旦决定开始JAKI。该委员会包括患者，风湿病学家,胃肠病学家,血液学家,皮肤科医生,传染病专家和健康专家。SLR向工作组通报了受控和开放临床试验，注册表数据，4期试验和荟萃分析。此外,新化合物的批准，并考虑了在SLR搜索日期结束后发布的监管机构的警告。
工作队商定并制定了四项一般原则和总共26个考虑要点，分为六个领域，涉及适应症，治疗剂量和昏迷，禁忌症,预处理筛查和风险，实验室和临床随访检查，和不良事件。根据SLR确定了建议的证据水平和优势，并就每一点进行了协议水平的表决，在10分制下达到8.8和9.9之间的范围。
共识提供了一个重要治疗类的有效性和安全性的评估证据，并指导了实际管理问题。
指导委员会对现有数据进行了评估，随后由一个29人的专家委员会进行了审查，从而制定了一份可能有助于临床医生的共识声明。患者和其他利益相关者一旦决定开始JAKI。该委员会包括患者，风湿病学家,胃肠病学家,血液学家,皮肤科医生,传染病专家和健康专家。SLR向工作组通报了受控和开放临床试验，注册表数据，4期试验和荟萃分析。此外,新化合物的批准，并考虑了在SLR搜索日期结束后发布的监管机构的警告。
工作队商定并制定了四项一般原则和总共26个考虑要点，分为六个领域，涉及适应症，治疗剂量和昏迷，禁忌症,预处理筛查和风险，实验室和临床随访检查，和不良事件。根据SLR确定了建议的证据水平和优势，并就每一点进行了协议水平的表决，在10分制下达到8.8和9.9之间的范围。
共识提供了一个重要治疗类的有效性和安全性的评估证据，并指导了实际管理问题。
